BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 1918326 · Received December 3, 2010

    Report

    Report Number
    2432235-2010-00177
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    August 26, 2010
    Report Date
    November 3, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE ON (B)(4) 2010 BASED ON A CUSTOMER COMPLAINT PERTAINING TO ON-GOING PROBLEMS WITH HIGH CALCIUM RESULTS. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE PERFORMED A DECONTAMINATION OF THE PURE WATER SYSTEM, PERFORMED PROBE MECHANICAL ALIGNMENTS, REPLACED SEALS ON THE SAMPLE PUMP, DILUTION PUMP AND REAGENT DISPENSE PUMP 1 AND FOUND A WORN SEAL ON REAGENT WASH PUMP 2. THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CORRECTED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH CALCIUM RESULT WAS OBTAINED FOR ONE PT ON AN ADVIA 1650. IT APPEARS A REPEAT TEST WAS NOT PERFORMED TO CONFIRM THIS RESULT. ON (B)(6) 2010, A PT HAD BLOOD DRAWN AS REQUESTED BY A RHEUMATOLOGIST. THE BLOOD WORK WAS DONE AS A PRECAUTION PRIOR TO RECLAST INFUSION (FOR OSTEOPOROSIS). THE PT RECEIVED A CALL THAT DAY FROM THE DR TO GO TO AN EMERGENCY FACILITY SINCE THE LAB REPORT SHOWED A HIGH CALCIUM RESULT (14.0 MG/DL). THE PT RECEIVED A DIURETIC INFUSION AND AN ELECTRO-CARDIOGRAM. A BLOOD RE-DRAW FROM THE HOSPITAL SHOWED A CALCIUM RESULT OF 9.1 MG/DL. SIEMENS WAS NOT MADE AWARE OF THE DETAILS PERTAINING TO PT INTERVENTION UNTIL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1